A researcher’s perspective on the Moderna COVID-19 vaccine
Medical director of the UCLA Vine Street Clinic played a key role in development of the vaccine, which has been granted emergency use authorization by FDA.
Jesse Clark, MD, has spent more than two decades focused on HIV prevention and treatment.
Then the coronavirus pandemic hit, and he became a COVID-19 researcher.
UCLA Vine Street Clinic, where Dr. Clark serves as medical director, was one of 100 clinical trial sites for the Moderna vaccine, which on Friday, Dec. 18, received emergency use authorization from the U.S. Food and Drug Administration. Shipment is expected immediately.
“The sense of optimism right now is really terrific,” he says. “Just seeing the results of the Moderna trial and the Pfizer trial and even the AstraZeneca trial — all are showing that we can develop these effective vaccines and we can prevent infection. The optimism is really inspiring.”
UCLA Vine Street Clinic was tapped to participate in COVID-19 vaccine trials because it already was part of the National Institutes of Health’s HIV prevention trials network.
“The NIH invested a tremendous amount of money and expertise and resources in getting this clinical trial network set up to do HIV research, and then they needed to have something already in place to very quickly mobilize for doing these large-scale COVID-19 vaccine and treatment studies,” Dr. Clark says. “This kind of infrastructure would normally take anywhere from five to 10 years to set up, so they could just flip a switch basically and be ready to go on day one.”
Dr. Clark and his team started recruiting for the Moderna vaccine study in late August. By mid-October, they had enrolled 194 volunteer participants, all of whom received their first injection on their first day in the study. Half of the participants were given the vaccine and half received a placebo, but because it’s a double-blind study, neither Dr. Clark nor the volunteers know who got which.
The second dose was given a month later, so all study doses had been administered by mid-November. Around that same time, Moderna announced that preliminary data showed its vaccine was more than 94% effective.
It’s the fastest-moving clinical trial Dr. Clark has ever been part of.
“As we were doing the study, everybody was working so hard and so fast that they didn’t really have time to look around and think about what was happening,” Dr. Clark says. “But once we heard the preliminary results and the fantastic almost 95% effectiveness in preventing COVID-19 infection, everybody was just over the moon — so proud to be a part of this, so happy with the results and so happy that this pandemic may actually be coming to an end.”
Another point of pride for Dr. Clark’s team was the diversity of Vine Street Clinic’s study group. “Our participant population was one of the highest proportions of non-white participants, so African-American and Latino participants,” he says, adding that the clinic is dedicated to serving people of color.
Study volunteers, too, feel the excitement of the vaccine’s promise, he says.
“Participants — a lot of whom enrolled in the study just for altruistic purposes — are thrilled that they were able to contribute to this and help put an end to the pandemic and make their contribution to history in terms of treating disease,” Dr. Clark says. “A lot of them are also very, very happy because they now have had access to a highly effective vaccine far faster than they would have otherwise, so the people who think that they've gotten the vaccine are ecstatic about that.”
They don’t know for sure, of course, because they may have gotten the placebo.
“I can tell you that half the people in the study seem to have had some symptoms that are consistent with having received the vaccine and half did not,” Dr. Clark says.
As the study progresses, his team continues to monitor the volunteers, who are completing electronic diaries of their symptoms and exposures.
While participants are advised to follow masking, social distancing and hand-washing precautions, some are still becoming infected as cases surge across the state and the country.
“We’re in this weird position right now: we’re following people for COVID and we haven’t vaccinated the placebo participants yet, so we’re actually now finding a higher incidence of disease,” Dr. Clark says. “So it’s this weird period where you’ve got this tremendous optimism, you see that there’s this light at the end of the tunnel, but you’re still in the tunnel.”